Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial
Northwestern University
Summary
Diverting ileostomy is frequently utilized to protect high-risk anastomoses, though it is not shown to reduce the leak rate it may reduce the severe consequences of an anastomotic leak. Ileostomy will be reversed with restoration of continuity in majority of patients. Stoma site incisional hernias after ileostomy closure are complex hernias that can be associated with abdominal pain, discomfort, and a diminished quality of life. Duramesh™ non-absorbable polypropylene suture is a hollow core, microporous, cylindrical suture made off in polypropylene filaments that are loosely braided and bonded to each other with heat and pressure. The Aim of this study is to evaluate Duramesh™ suture vs standard closure on rates of hernia formation after ileostomy closure.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * • Patients undergoing ileostomy closure after surgery for cancer All patients with a stoma (independent of diagnosis) * Age 18 or greater * Surgical oncology patient where routine radiologic surveillance for malignancy is planned * Patient accepts participation and gives informed consent Exclusion Criteria: * • Pregnancy * Prior mesh hernia repair at laparotomy site * Life expectancy less than 1 years * Patient is unable / unwilling to provide informed consent * Patient is unable to comply with the protocol or proposed follow-up visits * Patient is en…
Interventions
- Deviceduramesh
Duramesh™ non-absorbable polypropylene suture is a hollow core, microporous, cylindrical suture made off in polypropylene filaments that are loosely braided and bonded to each other with heat and pressure
- DeviceControl
standard closure of fascia
Location
- Northwestern University Feinberg School of MedicineChicago, Illinois